Tertiary Prevention of Child Sexual Abuse

Child Sexual Abuse Clinical Trial

Official title:

Mobilizing Evidence Into Tertiary Prevention of Child Sexual Abuse: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06126926
• Other study ID #: FMCH-2023-32331
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: Alexandra Hanson
• Phone: 612-626-9404
• Email: lessa030[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a feasibility study designed to inform the development of a multinational study of the effectiveness of a tertiary prevention program for child sexual abuse. This study targets adult men who have engaged in child sexual abuse, and will be implemented within the Minnesota Department of Corrections. Data will include measures of the implementation process, short-terms changes in criminogenic factors, and staff and participant factors that could influence outcomes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: March 1, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male

• 18 or older

• Serving time in MnDOC facilities for Criminal Sexual Conduct in the first, second, or third degree, whose victims were less than 14 years old

• Individuals assigned moderate to high risk to reoffend as determined upon entrance to the Minnesota Correctional System by the DOC Risk Assessment/Community Notification Unit."

Exclusion Criteria:

• Diagnosed with an active, uncontrolled major mental disorder (e.g. bi-polar, schizophrenia, schizoaffective disorder, major depression with psychotic features)

• Unable to read English at the 5th grade level

• Unable to speak English

• IQ of less than 85 as measured by standard intelligence tests

• Diagnosis of intellectual disability

• Engaged in violent behavior while incarcerated, as indicated by disciplinary actions and/or segregation within 60 days of intake"

Related Conditions & MeSH terms

• Child Sexual Abuse

Intervention

Behavioral:
• group therapy
32 weeks of group therapy

Other:
• Treatment as usual
Control participants remain in their current placement and may be eligible for a number of services offered to inmates to facilitate rehabilitation and planning for release to the community, including sexual offender treatment. MnDOC's sexual offender treatment is a two to three year program, thus most of our control subjects will not have enough time remaining on their sentences to complete such treatment. However, a number of them may participate in MnDOC's current program.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Violence Risk Scale-Sexual Offense Version (VRS:SO)	Clinician rating scale. 24-items measuring likelihood of sexual offense recidivism using a 4 point scale.	7 days post-intervention
Primary	Coping Using Sex Inventory (CUSI)	Self-report scale. 16 items measuring consensual, non-consensual, and child-focused sexual coping strategies using a 5-point scale	7 days post-intervention
Primary	Compulsive Sexual Behavior Inventory-13 (CSBI-13)	Self-report scale. 13 item scale measuring the presence of compulsive sexual behaviors on a 5- point scale.	7-days post-intervention
Primary	Types of Jealousy Scale (3 subscales; reactive, preventive, and anxious jealousy)	Self-report scale. 15 items measuring the intensity of reactive jealousy, experience and use of preventive jealousy, and frequency of anxious jealousy on a 5-point scale.	7 days post-intervention
Primary	Faith in People Scale	Self-report scale. 5 item scale measuring attitudes toward human nature. Two forced- choice items and three agreement/disagreement items.	7 days post-intervention
Primary	Trust in People Scale (Survey Research Center)	Self-report scale. 3 item scale measuring perception of general trustworthiness of others.	7 days post-intervention
Primary	Aggression Questionnaire (AQ; Buss &amp) - Physical Aggression, Verbal Aggression, and Anger Subscales ONLY	Self-report scale. 21 items throughout the 3 subscales measuring how characteristic physical aggression, verbal aggression, and anger-related behaviors are for respondents on a 7 point scale.	7 days post-intervention
Primary	Revised UCLA Loneliness Scale (R-UCLA)	Self-report scale. 20 items measuring subjective feelings of loneliness and social isolation on a 4 point scale.	7 days post-intervention
Primary	Self-Critical Rumination Scale (SCRS)	Self-report scale. 10 items measuring self- criticism on a 4 point scale.	7 days post-intervention
Primary	External/Internal Shame Scale - Sense of Isolation/Exclusion Subscale ONLY (EISS)	Self-report scale. Measures perceived sense of exclusion and being isolated or misunderstood by people on a 5 point scale.	7 days post-intervention
Primary	Children and Sex Questionnaire Emotional Congruence Scale (CSQ:ECWC)	Self-report scale. 15 item scale measuring emotional congruence with children on a 5 point scale.	7 days post-intervention
Primary	The Openness to Men and Women Scales (OPM, OPWO)	Self-report scale. 18 items assessing openness to intimacy with women and men on a 4 point scale.	7 days post-intervention
Primary	Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)	Self-report scale. 18 items measuring problems with emotion regulation including subscales for strategies, non-acceptance, impulse, goals, awareness, and clarity on a 5 point scale.	7 days post-intervention
Primary	Coping Strategy Indicator (CSI)	Self-report scale. 33 items measuring adaptive and maladaptive coping strategies (avoidance, problem-solving, social support seeking) on a 3 point scale.	7 days post-intervention
Primary	Aggression Inventory (AI)- Impulsive, Impatient, and Avoid subscales ONLY	Self-report scale. 22 item scale measuring perceptions and use of aggressive behaviors for men a women on a 5 point scale.	7 days post-intervention
Secondary	Group Climate Questionnaire - Short Form (GCQ-5)	Self-report scale. 12 items measuring group perceptions of the group therapeutic environment on a 7 point scale.	Every 14 days for first two months, than every four weeks for next four months
Secondary	Curative Climate Instrument (CCI)	Self-report scale. 14 items measuring specific change processes perceived as helpful to individual group members (catharsis, insight, and cohesiveness) on a 5 point scale.	Every 14 days for first two months, than every four weeks for next four months
Secondary	Treatment Motivation Questionnaire-Revised (TMQ-R)	Self-report scale. 23 items measuring internal and external reasons for participating in treatment, motivations relating to connecting and sharing with others, and clients' potential lack of confidence in treatment on a 7 point scale.	Every 14 days for first two months, than every four weeks for next four months
Secondary	Therapeutic Agency Inventory (TAI)	Self-report scale. 15 items measuring clients' experience of agency in making positive change and ability to take an active role in their therapy on a 5 point scale.	Every 14 days for first two months, than every four weeks for next four months
Secondary	Relationship Questionnaire (RQ)	Self-report scale. 4 items measuring adult attachment style on a 7 point scale.	Every 14 days for first two months, than every four weeks for next four months
Secondary	Working Alliance Inventory - Short Form (WAI- SR)	Self-report scale. 12 items measuring three domains of the therapeutic alliance: goals, tasks, and bond on a 5 point scale.	Every 14 days for first two months, than every four weeks for next four months